Taiwan FDA registration b5f50662656ca5e0a820e5ec92059191

"Xian Kangtaku" Manual instrument for general surgery (not sterilized)

TW: "西安康拓" 一般手術用手動式器械 (未滅菌)

Taiwan·Risk Class 1·Kontour (Xi'an) Medical Technology Co., Ltd.·Registered Sep 16, 2022 – Sep 16, 2027Active

Registration details

Analysis ID: b5f50662656ca5e0a820e5ec92059191
Customs Code: DHA09600467400

Company information

Manufacturer: Kontour (Xi'an) Medical Technology Co., Ltd.
Manufacturer Country: China
Authorized Representative: MATECH HEALTHCARE CORPORATION

Product details

Intended Use: Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Hand Instruments for General Surgery
Import Information: Input;; Chinese goods;; QMS/QSD

Dates and status

Registration Date: Sep 16, 2022
Expiry Date: Sep 16, 2027

About this record

Access comprehensive regulatory information for "Xian Kangtaku" Manual instrument for general surgery (not sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b5f50662656ca5e0a820e5ec92059191 and manufactured by Kontour (Xi'an) Medical Technology Co., Ltd.. The authorized representative in Taiwan is MATECH HEALTHCARE CORPORATION.

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